Efficacy of Antimicrobial Photodynamic Therapy Using Polymeric Nanoparticles Loaded With Indocyanine Green in Management of Periodontitis.(A Randomized Controlled Clinical Trial Study With Microbiological Analysis )
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Plaque Index (unit:score)
研究概览
简要总结
To better understand and treat your gum disease, dentists now use a system that stages its severity and grades its speed, rather than using old labels. The recommended first step is almost always a deep cleaning, which is very effective. However, because some bacteria can hide from cleanings and antibiotics, researchers are exploring a promising light-based treatment. This method uses a safe, light-activated dye and a gentle laser to target and kill bacteria without leading to resistance. To make this treatment even stronger, scientists are testing a way to package the dye inside tiny, biodegradable "containers" that deliver it directly to the germs. The goal of this research is to see if this advanced delivery method works better than the dye alone, hoping to provide a more powerful, non-surgical option to fight gum disease and protect your teeth."
详细描述
This randomized controlled clinical trial included twenty-seven patients diagnosed with generalized stage III periodontitis, who were randomly allocated into three groups using a computer-generated randomization sequence (www.randomizer.org
). Group I (test group) received non-surgical periodontal therapy followed by the application of indocyanine green (ICG)-loaded polymeric nanoparticles and antimicrobial photodynamic therapy (aPDT). Group II (positive control) received non-surgical periodontal therapy with ICG gel application alone and aPDT, whereas Group III (negative control) received non-surgical periodontal therapy only. Following full-mouth supra- and subgingival debridement, baseline clinical measurements and gingival crevicular fluid (GCF) samples were obtained. In Groups I and II, after achieving site dryness, the photosensitizer was applied for 10 minutes, rinsed, and activated using a 940 nm diode laser (0.5 W, continuous mode, non-initiated E3 tip, contact mode, 30 seconds per site, six sites per tooth). Standardized oral hygiene instructions were provided to all participants. Clinical and microbiological evaluations were performed at baseline, 3 months, and 6 months post-treatment. Clinical parameters including plaque index, gingival index, probing depth, and clinical attachment level were recorded using a UNC-15 probe. For microbiological analysis, GCF samples from the most affected sites were collected at baseline, immediately post-treatment, 1 week, and 1 month, and analyzed by polymerase chain reaction (PCR) to quantify Porphyromonas gingivalis. Samples contaminated with blood or saliva were excluded, and uncontaminated samples were transported in reduced transport fluid (RTF) and cultured under anaerobic conditions for bacterial quantification.
The obtained results will be collected, tabulated, and subjected to appropriate statistical analysis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 36 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1- Both genders aged between 36-50 years (Wadhwa et al., 2021) 2- Generalized stage III grade B periodontitis (Papapanou et al., 2018). Posterior teeth, stage III with PD>6 mm and CAL ≥5 mm 3- Patients ready to comply with oral hygiene measures. 4- Patients free from any systemic disease that may affect the treatment (Glick et al., 2008)
排除标准
- •Exclusion criteria:
- •Pregnant females.
- •Drug abusers.
- •Patients taking antibiotics or performed any periodontal treatment in the previous 6 months.
- •Justification for Exclusions:
- •To reduce any confounding factors and bias that may affect the results of this study.
研究组 & 干预措施
Nano Group
This group will include 9 patients diagnosed with generalized stage III periodontitis and will be treated with non-surgical periodontal treatment + ICG-loaded polymeric nanoparticles + antimicrobial photodynamic therapy (aPDT).
干预措施: Non- surgical periodontal therapy followed by photodynamic therapy with ICG-loaded nanoparticles (Drug)
Macro Group( positive control)
Group (II): Positive Control This group will include 9 patients diagnosed with generalized stage III periodontitis and will be treated with non-surgical periodontal treatment + ICG gel application alone + antimicrobial photodynamic therapy.
干预措施: Non- surgical periodontal therapy followed by photodynamic therapy with ICG-loaded macroparticles (Drug)
Negative Control
Group (III): Negative Control This group will include 9 patients diagnosed with stage III periodontitis and will be treated with non-surgical periodontal therapy only.
干预措施: Non- surgical periodontal therapy only (Other)
结局指标
主要结局
Plaque Index (unit:score)
时间窗: from the enrollment to the end of treatment at 6 months the clinical parameters are first measured at baseline through stent for standaridization and then measured again after 3 months and 6 months repectively .
Clinical parameters including plaque index, gingival index, probing pocket depth (PPD), and clinical attachment level (CAL) will be recorded at baseline, 3, and 6 months using a UNC-15 probe by a calibrated examiner. The plaque and gingival indices (Löe and Silness, 1963) assess oral hygiene and inflammation. The following clinical parameters will be taken using the UNC15 Probe at baseline, 3 months, and 6 months postoperative. \- Plaque index: - (Loe and Silness, 1963) 0 = no plaque. 1. = plaque recognized only by running a probe across the marginal surface of implant restoration. 2. = plaque visible to the naked eye. 3. = abundance of soft matter.
The Gingival index (unit=score )
时间窗: from the enrollment to the end of treatment at 6 months the clinical parameters are first measured at baseline through stent for standaridization and then measured again after 3 months and 6 months repectively .
The following clinical parameters will be taken using UNC15 Probe at baseline, 3 months and 6 months postoperative. \- Gingival index: -(Loe and Silness ,1963) 0 = Normal gingiva 1. = Mild inflammation - slight edema. No bleeding on probing 2. = Moderate inflammation -redness, edema and glazing. Bleeding on probing. 3. = Severe inflammation - marked redness and edema. Ulceration. Tendency to spontaneous bleeding
Probing depth (PD) (Unit=mm)
时间窗: from the enrollment to the end of treatment at 6 months the clinical parameters are first measured at baseline through stent for standaridization and then measured again after 3 months and 6 months repectively .
Will be measured from the gingival margin to the depth of the pocket at four points (mesio-facial, mid-facial, disto-facial and mid-lingual) to the nearest millimeter using UNC-15 periodontal probe The average of the three facial points will be recorded as the facial probing depth (FPD), while the mid-lingual point will be recorded as the lingual probing depth.
Clinical Attachment Loss (CAL) (Unit=mm)
时间窗: from the enrollment to the end of treatment at 6 months the clinical parameters are first measured at baseline through stent for standaridization and then measured again after 3 months and 6 months repectively .
\- Clinical attachment level (CAL): (Ramfjord et al., 1975). Will be measured from the CEJ to the depth of the periodontal pocket.
次要结局
- Microbial evaluation to detect bactericidal effect on Porhyromonas gingivalis.(from enrollment to the end of treatment at 6 months GCF samples will be collected from the deepest, most affected sites at baseline line , immediate postlaser treatment and after one month respectively)
研究者
Nada Mahmoud Soliman
master Candidate at oral medicine and periodontology department faculty of dentistry ainshams university
Ain Shams University